Bupropion hydrobromide - Generic Drug Details

What are the generic sources for bupropion hydrobromide and what is the scope of freedom to operate?

Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrobromide has fifty-two patent family members in eighteen countries.

There are five drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for bupropion hydrobromide

International Patents:	52
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bupropion hydrobromide
What excipients (inactive ingredients) are in bupropion hydrobromide?	bupropion hydrobromide excipients list
DailyMed Link:	bupropion hydrobromide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for bupropion hydrobromide

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for bupropion hydrobromide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bausch Health Americas, Inc.	Phase 4
Valeant Pharmaceuticals International, Inc.	Phase 4
Alphacait, LLC	Phase 2

See all bupropion hydrobromide clinical trials

Generic filers with tentative approvals for BUPROPION HYDROBROMIDE

Applicant	Application No.	Strength	Dosage Form
		522MG	TABLET, EXTENDED RELEASE; ORAL
		174MG	TABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bupropion hydrobromide

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Anatomical Therapeutic Chemical (ATC) Classes for bupropion hydrobromide

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for BUPROPION HYDROBROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APLENZIN	Extended-release Tablets	bupropion hydrobromide	522 mg	022108	1	2009-12-24
APLENZIN	Extended-release Tablets	bupropion hydrobromide	174 mg	022108	1	2009-09-28
APLENZIN	Extended-release Tablets	bupropion hydrobromide	348 mg	022108	1	2009-09-24

US Patents and Regulatory Information for bupropion hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y

International Patents for bupropion hydrobromide

Country	Patent Number	Title	Estimated Expiration
Nicaragua	201000015	BROMHIDRATO DE BUPROPIÓN Y APLICACIONES TERAPÉUTICAS
World Intellectual Property Organization (WIPO)	2009019294
Israel	185760
Nicaragua	201000044	BROMHIDRATO DE BUPROPIÓN Y APLICACIONES TERAPÉUTICAS
European Patent Office	2214650	BROMHYDRATE DE BUPROPIONE ET SES APPLICATIONS THÉRAPEUTIQUES (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS)
South Korea	101306635
World Intellectual Property Organization (WIPO)	2009056550

Supplementary Protection Certificates for bupropion hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	CR 2017 00062	Denmark		PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
2316456	122017000109	Germany		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	300918	Netherlands		PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	C 2017 047	Romania		PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	LUC00054	Luxembourg		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330

Bupropion Hydrobromide: Patent Landscape and Market Trajectory

Last updated: February 19, 2026

Bupropion hydrobromide, an aminoketone antidepressant, holds a significant position in the pharmaceutical market, primarily for its efficacy in treating major depressive disorder (MDD) and its use as a smoking cessation aid. The drug's market trajectory is shaped by its patent expiration, the emergence of generic competition, and ongoing research into new formulations and indications. Understanding these dynamics is critical for stakeholders evaluating R&D investments and market opportunities.

What are the Key Patents Covering Bupropion Hydrobromide?

The patent history of bupropion hydrobromide is a critical determinant of its market exclusivity and the subsequent entry of generic alternatives. Original patents, while expired, paved the way for extended market protection through formulation patents and method-of-use patents.

The foundational patent for bupropion was filed by Burroughs Wellcome (now part of GlaxoSmithKline) in the late 1960s. U.S. Patent No. 3,957,747, for example, claimed bupropion and its salts, including the hydrobromide form. This patent provided initial market exclusivity.

Following the initial patent, further patent filings focused on improving drug delivery and patient compliance. Extended-release formulations became a key area of patent activity. For instance, patents covering sustained-release and controlled-release formulations were developed to mitigate side effects and improve dosing convenience. These formulations often differed from the immediate-release versions, allowing for new patent protection periods.

• U.S. Patent No. 4,900,547: This patent, related to a sustained-release formulation of bupropion, was significant in extending market exclusivity. It claimed a specific pharmacokinetic profile achievable through a particular formulation design.
• U.S. Patent No. 5,427,798: This patent also targeted extended-release formulations, aiming for specific release characteristics over a 24-hour period.
• U.S. Patent No. 6,572,899: This patent covered a specific biphasic extended-release formulation, allowing for both rapid and sustained release of the active ingredient. This innovation was crucial for the development of products like Wellbutrin XL.

The expiration of these key patents, particularly those covering the extended-release formulations, has led to significant shifts in the market landscape, allowing generic manufacturers to introduce their versions of the drug. The exact expiration dates vary by patent and jurisdiction, but the majority of patents covering the most commercially successful formulations have now lapsed in major markets like the United States and Europe.

How Has Generic Competition Impacted Bupropion Hydrobromide Pricing and Market Share?

The entry of generic bupropion hydrobromide has profoundly impacted the drug's market dynamics, characterized by significant price erosion and a redistribution of market share.

Prior to the expiration of key patents, particularly for extended-release formulations, bupropion hydrobromide, marketed under brand names like Wellbutrin XL, commanded premium pricing. The extended-release versions offered improved patient outcomes and convenience, justifying higher costs.

Upon patent expiration, generic manufacturers, such as Teva Pharmaceuticals, Sun Pharmaceutical Industries, and Mylan (now Viatris), were able to introduce bioequivalent versions of the drug. This influx of competition typically leads to:

1. Price Reduction: Generic versions are generally priced significantly lower than their branded counterparts. This reduction can be as high as 50-80% or more, depending on the number of generic competitors and the negotiation power of pharmacy benefit managers (PBMs) and payers.
   • In the United States, the average wholesale price (AWP) for brand-name bupropion extended-release tablets (e.g., 300 mg, 30-count) has fallen from several hundred dollars pre-generic entry to less than fifty dollars for generic equivalents.
2. Market Share Shift: Generic penetration is rapid once approved and available. Within months of generic launch, the market share for the branded product typically declines substantially.
   • For bupropion extended-release, generic versions often capture over 90% of the market within two to three years of their introduction.
3. Increased Volume: While revenue per unit decreases, the overall volume of bupropion hydrobromide prescribed often increases due to its lower cost, making it more accessible to a wider patient population and a preferred choice for formulary placement by PBMs.

The financial trajectory for the original innovator is marked by a sharp decline in revenue for the affected product lines following generic entry. Conversely, generic manufacturers experience revenue growth driven by increased sales volume and market penetration. The market for bupropion hydrobromide has transitioned from one dominated by a few branded products to a highly competitive generic landscape.

What are the Primary Approved Indications for Bupropion Hydrobromide?

Bupropion hydrobromide is approved for specific therapeutic uses, primarily related to mental health and addiction. These approved indications define its primary market segments.

The two main approved indications are:

1. Major Depressive Disorder (MDD): Bupropion is indicated for the treatment of MDD in adults. It is often used as a first-line or second-line treatment. Its mechanism of action, primarily as a norepinephrine and dopamine reuptake inhibitor (NDRI), differentiates it from selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), making it a valuable option for patients who do not respond well to or tolerate other antidepressants.
2. Smoking Cessation: Bupropion is also approved as a prescription medication to help people quit smoking. It is believed to reduce nicotine cravings and withdrawal symptoms. The drug's efficacy in this area has made it a cornerstone of smoking cessation programs.

In addition to these primary indications, bupropion has been explored for off-label uses, including:

• Attention-Deficit/Hyperactivity Disorder (ADHD): Some studies suggest bupropion may be effective in treating ADHD symptoms, though it is not an FDA-approved indication.
• Bipolar Disorder: It can be used in conjunction with mood stabilizers for depressive episodes in bipolar disorder, but caution is advised due to potential for inducing manic episodes.
• Seasonal Affective Disorder (SAD): Due to its antidepressant properties, it is sometimes prescribed for SAD.

The market for bupropion hydrobromide is therefore bifurcated, serving both the large and evergreen market for depression treatment and the targeted market for smoking cessation. The approval status in different countries may vary, but these two indications represent the core of its global market.

What is the Current R&D Landscape for Bupropion Hydrobromide and Related Compounds?

The research and development landscape for bupropion hydrobromide is characterized by incremental innovation aimed at optimizing existing formulations and exploring potential new therapeutic avenues or combinations. While the core molecule is well-established, ongoing R&D efforts are focused on enhancing its clinical utility and market differentiation.

Current R&D activities include:

1. New Formulations:
   • Improved Extended-Release Technologies: Development of novel drug delivery systems that offer even more precise control over drug release kinetics, potentially leading to reduced dosing frequency, fewer side effects, or improved efficacy. This could involve osmotic pump systems, matrix tablets, or encapsulation technologies.
   • Combination Products: Research into fixed-dose combinations of bupropion with other therapeutic agents. For example, combining bupropion with other antidepressants to achieve synergistic effects or broader symptom coverage, or combining it with agents to manage specific side effects associated with bupropion itself.
2. Exploration of New Indications:
   • Obesity/Weight Management: Bupropion, often in combination with naltrexone, has been developed for chronic weight management. While this specific combination (e.g., Contrave) is a separate product, it highlights ongoing interest in bupropion's potential role in metabolic health.
   • Other Psychiatric Conditions: While not primary targets, researchers continue to investigate bupropion's potential efficacy in other mood disorders or neurodevelopmental conditions where dopaminergic and noradrenergic pathways are implicated.
3. Pharmacogenomics and Personalized Medicine: Research into how individual genetic variations influence bupropion's metabolism and response. This could lead to more personalized dosing strategies to maximize efficacy and minimize adverse events.
4. Life Cycle Management for Generics: Generic manufacturers may invest in developing their own improved formulations or exploring new market segments to differentiate their offerings even within the generic space.

The financial commitment to bupropion hydrobromide R&D by major pharmaceutical companies has shifted since its peak branded sales. Much of the current innovation is driven by specialty pharmaceutical companies or generic manufacturers looking to extend product life cycles or enter niche markets. The cost of developing entirely new chemical entities (NCEs) is substantial, and for a well-established drug like bupropion, R&D is more likely to focus on formulation enhancements and life cycle management rather than groundbreaking new molecule discovery.

What are the Future Market Projections for Bupropion Hydrobromide?

The future market for bupropion hydrobromide is projected to remain stable, primarily driven by its established efficacy, broad physician acceptance, and its competitive pricing as a generic medication.

Key factors influencing future market projections include:

1. Sustained Demand for Depression Treatment: MDD is a chronic condition with persistent demand for effective and accessible treatments. Bupropion's position as a well-tolerated and effective antidepressant, particularly for specific patient profiles, ensures continued prescription volume.
2. Ongoing Smoking Cessation Needs: Public health initiatives and awareness campaigns aimed at reducing smoking rates worldwide will continue to drive demand for effective cessation aids. Bupropion remains a recognized and utilized option.
3. Generic Market Dominance: The market will continue to be dominated by generic manufacturers. Pricing will remain competitive, emphasizing volume-driven sales rather than high margins per unit. Market growth will likely be moderate, reflecting population growth and an increasing prevalence of diagnosed mental health conditions, rather than significant price increases.
4. Potential for New Formulations/Combinations: While the pipeline for entirely new bupropion-based drugs is not extensive, successful development of novel formulations or effective fixed-dose combinations could create new market segments or revitalize interest in specific therapeutic applications. However, the impact of such developments on the overall market size is likely to be incremental.
5. Regulatory and Reimbursement Policies: Government regulations, healthcare reforms, and insurance reimbursement policies will continue to influence prescribing patterns and access to both branded (if any limited niche products remain) and generic bupropion hydrobromide. The cost-effectiveness of generic bupropion will likely ensure its favorable reimbursement status.

The market value of bupropion hydrobromide will largely be determined by the collective sales volume of its generic versions. While specific dollar figures are subject to market fluctuations and competitive pressures, the drug is expected to maintain its status as a significant contributor to the antidepressant and smoking cessation markets for the foreseeable future. The overall market trajectory is one of steady, mature demand rather than rapid growth or decline.

Key Takeaways

• Bupropion hydrobromide's patent exclusivity has largely expired, leading to a highly competitive generic market.
• Generic entry has resulted in substantial price erosion and a significant shift in market share away from branded products.
• The drug's primary indications are major depressive disorder and smoking cessation, defining its core market segments.
• Current R&D focuses on formulation optimization, combination products, and exploration of new therapeutic uses, rather than novel molecule discovery.
• Future market projections indicate stable demand driven by its established efficacy, broad physician acceptance, and cost-effective generic availability.

Frequently Asked Questions

1. What is the typical shelf life of bupropion hydrobromide? The shelf life of pharmaceutical products, including bupropion hydrobromide, is determined by stability testing and is typically indicated on the product packaging, generally ranging from 18 to 36 months from the date of manufacture.
2. Are there any significant safety concerns associated with bupropion hydrobromide that could impact its market? Bupropion hydrobromide has known contraindications and warnings, including seizure risk, particularly at higher doses or in individuals with predisposing factors. It also carries warnings regarding neuropsychiatric events and suicidal thoughts/behaviors, especially in younger patients. These are well-documented and managed through prescribing information and patient counseling.
3. What is the difference in cost between brand-name bupropion and its generic equivalents? Generic equivalents of bupropion hydrobromide are typically priced at 50-80% less than the original branded formulations, depending on the specific product, dosage, and number of generic manufacturers in the market.
4. Can bupropion hydrobromide be used off-label for conditions other than depression and smoking cessation? Yes, bupropion hydrobromide is sometimes prescribed off-label for conditions such as ADHD and bipolar depression, though its efficacy and safety for these uses are not as well-established as for its approved indications.
5. What is the mechanism of action of bupropion hydrobromide? Bupropion hydrobromide is a norepinephrine and dopamine reuptake inhibitor (NDRI). It works by increasing the levels of these neurotransmitters in the brain, which is thought to help alleviate symptoms of depression and reduce nicotine cravings.

Citations

[1] U.S. Patent No. 3,957,747. (1976). Chemical Abstracts Service. [2] U.S. Patent No. 4,900,547. (1990). Chemical Abstracts Service. [3] U.S. Patent No. 5,427,798. (1995). Chemical Abstracts Service. [4] U.S. Patent No. 6,572,899. (2003). Chemical Abstracts Service. [5] U.S. Food & Drug Administration. (n.d.). Drug Database. Retrieved from www.accessdata.fda.gov [6] Industry market analysis reports (various publishers, 2010-2023).